Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00383123

Purpose

The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Condition	Intervention	Phase
Influenza Influenza Vaccines	Biological: Fluarix™ Biological: Fluzone	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Official Title:	A Phase III, Single-blind, Randomized Study to Evaluate the Immunogenicity and Safety of Fluarix® (GSK Biologicals) Compared With Fluzone® (Aventis Pasteur/Sanofi) Administered Intramuscularly in Children (6 Months and Older)

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies [ Time Frame: 21 or 28 days after last vaccine dose ] [ Designated as safety issue: No ]
GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.
Number of Seroconverted Subjects [ Time Frame: 21 or 28 days after last vaccine dose ] [ Designated as safety issue: No ]
Seroconverted subjects are defined as subjects with either a pre-vaccination HI titer <1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer.

Data are presented for all 3 viral strains comprised in the vaccine.
Number of Subjects Reporting Rare Serious Events [ Time Frame: Up to 6 months after vaccination ] [ Designated as safety issue: No ]
Rare serious event is defined as any untoward medical event with an occurrence rate of ≥1/300 that:
- resulted in death,
- was life-threatening,
- required hospitalization or prolongation of existing hospitalization,
- resulted in disability/incapacity, or
- was a congenital anomaly/birth defect in the offspring of a study subject.

Secondary Outcome Measures:

Number of Seroprotected Subjects [ Time Frame: Before (PRE) and 21 or 28 days after (POST) the last vaccine dose ] [ Designated as safety issue: No ]
Seroprotected subjects are defined as vaccinees with a serum HI titer ≥ 1:40. Data are presented for all 3 viral strains comprised in the vaccine.
Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer [ Time Frame: 21 or 28 days after last vaccine dose ] [ Designated as safety issue: No ]
Initially unprotected subjects are subjects with a baseline HI titer < 1:40. Data are presented for all 3 viral strains comprised in the vaccine.
Number of Subjects Reporting Solicited Local and General Symptoms [ Time Frame: During a 4-day follow-up period after each vaccination ] [ Designated as safety issue: No ]
Solicited local symptoms assessed include pain, redness, and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, loss of appetite, arthralgia, fatigue, headache, muscle aches, and shivering.

Data across doses are presented. Any = at least one symptom irrespective of intensity/relationship to vaccination; Grade 3: symptom that prevented normal everyday activities; Related: considered by the investigator as related to the study vaccination.
Number of Subjects Reporting Unsolicited Adverse Events [ Time Frame: Within 28 days following vaccination ] [ Designated as safety issue: No ]
An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Any = at least one symptom irrespective of intensity and relationship to vaccination; Grade 3 = preventing normal activity; Related = considered by the investigator to be causally related to the study vaccination.
Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE) [ Time Frame: Up to 6 months after vaccination ] [ Designated as safety issue: No ]
SAE: any untoward medical occurrence that
- resulted in death,
- was life-threatening,
- required hospitalization or prolongation of existing hospitalization,
- resulted in disability/incapacity, or
- was a congenital anomaly/birth defect in the offspring of a study subject.
Examples of possible new onset chronic illnesses include but are not limited to diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders.

Enrollment:	3327
Study Start Date:	November 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Fluarix Group Subjects in this group received Fluarix™ and will be further stratified by 3 age groups 1:1 in 6 months to < 36 months 1:1 in 3 to < 5 years 3:1 in 5 to < 18 years	Biological: Fluarix™ Subjects were administered 1 or 2 doses* intramuscularly, into the non-dominant upper arm for children > 12 months of age, in the anterolateral thigh for children < 12 months. *Only those subjects between the age of 6 months and < 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 & 1.
Active Comparator: Fluzone Group Subjects in this group received Fluzone and will be further stratified by 3 age groups 1:1 in 6 months to < 36 months 1:1 in 3 to < 5 years 3:1 in 5 to < 18 years	Biological: Fluzone Subjects were administered 1 or 2 doses* intramuscularly, into the non-dominant upper arm for children > 12 months of age, in the anterolateral thigh for children < 12 months. *Only those subjects between the age of 6 months and < 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 & 1.

Eligibility

Ages Eligible for Study:	6 Months to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A male or female child age 6 months to < 18 years at the time of the vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
Written informed consent obtained from the subject's parent/guardian; assent obtained in subjects > 10 years.
Female subjects of childbearing potential must agree to take a pregnancy test.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine, other than the study vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion.
History of hypersensitivity to any vaccine.
History of allergy or reactions likely to be exacerbated by any component of the vaccine.
Acute disease at the time of enrollment.
History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
Pregnant or lactating female.
Receipt of an influenza vaccine outside of this study, during current (2006-07) flu season.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00383123

Show 36 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Baxter R, Jeanfreau R, Block SL, Blatter M, Pichichero M, Jain VK, Dewé W, Innis BL. A Phase III evaluation of immunogenicity and safety of two trivalent inactivated seasonal influenza vaccines in US children. Pediatr Infect Dis J. 2010 Oct;29(10):924-30.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00383123 History of Changes
Other Study ID Numbers:	104858
Study First Received:	September 29, 2006
Results First Received:	October 15, 2008
Last Updated:	December 15, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Fluarix
Influenza

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 24, 2012